32 Participants Needed

Intermittent Fasting for Brain Health

AY
AC
Overseen ByAna Clara da Costa Pinaffi Langley, MSc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are diabetic and taking certain medications like sulfonylureas, meglitinides, or insulin, you cannot participate in the trial.

What data supports the effectiveness of the treatment Intermittent Fasting for brain health?

Research shows that intermittent fasting may have benefits for brain health, particularly in conditions like epilepsy, Alzheimer's disease, and multiple sclerosis, by improving disease symptoms and progress. Animal studies suggest potential benefits for other brain-related disorders, but more human studies are needed to confirm these effects.12345

Is intermittent fasting safe for humans?

Research on alternate-day fasting, a type of intermittent fasting, shows it is generally safe for weight loss in both obese and non-obese individuals, with no major safety concerns reported. However, more studies are needed to fully understand its long-term effects on health beyond weight loss.46789

How does intermittent fasting differ from other treatments for brain health?

Intermittent fasting is unique because it involves alternating periods of eating and fasting, which can lead to changes in brain function through metabolic, cellular, and circadian mechanisms. Unlike traditional treatments that may focus on medication or supplements, intermittent fasting leverages the body's natural processes to potentially improve brain health and cognitive function.1231011

What is the purpose of this trial?

The central hypothesis of this study is that closer adherence to time restricted eating (TRE) will improve endothelial function, neurovascular (NVC) responses, resulting in improved cognitive performance, potentially through activation of SIRT1-dependent vasoprotective pathways.

Research Team

AY

Andriy Yabluchanskiy, MD, PhD

Principal Investigator

University of Oklahoma

Eligibility Criteria

This trial is for individuals aged between 55 and 80 who can read, write, and understand English. They should be mentally competent to consent and have a Mini-Mental State Exam score of at least 24. It's not suitable for those with major psychiatric diseases, uncontrolled substance abuse issues, certain diabetics on specific medications, or anyone with recent severe brain-related health events.

Inclusion Criteria

Ability to read and write in English
You have a score of 24 or higher on a test that measures your thinking and memory abilities.
I can see and hear well enough to take part in exams.
See 2 more

Exclusion Criteria

You have difficulty seeing or hearing, which would make it hard for you to complete the study assessments.
I have not had a stroke, except for a TIA, in the last 60 days.
I am diabetic and take sulfonylureas, meglitinides, or insulin.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants adhere to a time restricted eating schedule with a 10-hour eating window each day

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Intermittent Fasting
Trial Overview The study tests if sticking closely to intermittent fasting (eating within a set time frame each day) improves brain function in older adults. The focus is on whether this eating pattern enhances cognitive abilities by improving blood vessel function in the brain through certain protective pathways.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Time restricted eatingExperimental Treatment1 Intervention
not more than 10 hrs. eating window daily goal for 6 months

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

Intermittent fasting, particularly alternate-day fasting, has been shown to effectively reduce body weight by approximately 3%-7% and body fat by about 3-5.5 kg over periods of 3 to 12 weeks in various populations, including normal-weight, overweight, and obese individuals.
Whole-day fasting lasting 12 to 24 weeks also leads to significant reductions in body weight (≈3%-9%) and improvements in blood lipids, with total cholesterol decreasing by 5%-20% and triglycerides by 17%-50%.
Effects of intermittent fasting on body composition and clinical health markers in humans.Tinsley, GM., La Bounty, PM.[2018]
A systematic review identified only three randomized controlled trials on fasting in humans, all showing improvements in surrogate outcomes like weight and cholesterol, but no trials focused on actual clinical events like diabetes or coronary artery disease.
While some observational studies suggest fasting may lower the prevalence of conditions like coronary artery disease and diabetes, the overall lack of rigorous clinical trials means more research is needed before fasting can be confidently recommended as a health intervention.
Health effects of intermittent fasting: hormesis or harm? A systematic review.Horne, BD., Muhlestein, JB., Anderson, JL.[2023]
Intermittent fasting (IF) has shown potential benefits for brain health and cognitive function, particularly in animal models, but there is currently no clear evidence of short-term cognitive improvements in healthy humans.
Clinical studies suggest that IF may help manage symptoms and progression of brain disorders such as epilepsy, Alzheimer's disease, and multiple sclerosis, indicating its potential as a therapeutic intervention.
The Effects of Intermittent Fasting on Brain and Cognitive Function.Gudden, J., Arias Vasquez, A., Bloemendaal, M.[2021]

References

Effects of intermittent fasting on body composition and clinical health markers in humans. [2018]
Health effects of intermittent fasting: hormesis or harm? A systematic review. [2023]
The Effects of Intermittent Fasting on Brain and Cognitive Function. [2021]
The role of intermittent fasting and meal timing in weight management and metabolic health. [2020]
Short-term modified alternate-day fasting: a novel dietary strategy for weight loss and cardioprotection in obese adults. [2023]
Alternate day fasting for weight loss in normal weight and overweight subjects: a randomized controlled trial. [2021]
Intermittent Fasting (Alternate Day Fasting) in Healthy, Non-obese Adults: Protocol for a Cohort Trial with an Embedded Randomized Controlled Pilot Trial. [2022]
Safety of alternate day fasting and effect on disordered eating behaviors. [2018]
A randomized pilot study comparing zero-calorie alternate-day fasting to daily caloric restriction in adults with obesity. [2019]
Eating behavior traits of successful weight losers during 12 months of alternate-day fasting: An exploratory analysis of a randomized controlled trial. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Alternate-day versus daily energy restriction diets: which is more effective for weight loss? A systematic review and meta-analysis. [2021]
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